Identity
- Trade Name
- Disposable Oxygen Mask EUDAMED
- Device Name
- Disposable Oxygen Mask EUDAMED
- Model / Reference
- HS-MZ01XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391490 EUDAMED
- Basic UDI-DI
- B-06944375391490 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Oxygen Mask by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375391490 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d30b2382-3fa9-4de7-ad7d-f851418a2b8b 61 fields · synced Jun 19, 2026